Clinical Trials Logo

Clinical Trial Summary

A-007 is an investigational therapy which may be effective in the treatment of pre-cancerous cervical dysplasia (abnormal cell growth). The purpose of this study is to evaluate the safety and efficacy of A-007, when used to treat high-grade cervical dysplasia.


Clinical Trial Description

This is a non-randomized, two-stage phase II study with pathological response rate as the primary objective. Following biopsy confirmation of CIN 2/3 within the last 12 weeks, women will treat themselves with gel applied to the cervix via an intravaginal applicator. Patients will apply gel once daily for 14 consecutive days of a 28-day cycle for 2 cycles.

Women will return to clinic for safety assessments, colposcopy, cytology, and virologic and immunologic testing (see schedule of events in attachment TG-003.01 for visit intervals).

Following the two cycles of treatment with A-007, treating physicians will perform a LEEP at the month 4 visit. The investigator is responsible for ensuring that the LEEP is conducted according to the procedures and guidelines of their institution. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00596258
Study type Interventional
Source Tigris Pharmaceuticals
Contact
Status Completed
Phase Phase 2
Start date November 2007
Completion date August 2008

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04537156 - Efficacy, Immunogenicity and Safty Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli) Phase 3
Completed NCT02907333 - Testing Use of Condoms on Regression of Cervical Intraepithelial Neoplasia N/A
Recruiting NCT02576262 - HPV Integration Testing for Human Papillomavirus-Positive Women N/A
Completed NCT01029990 - Randomized Controlled Trial to Study Interventions to Increase Participation in Cervical Cancer Screening Program Phase 0
Recruiting NCT05078528 - Low-cost Imaging Technology for Global Prevention of Cervical Cancer N/A
Recruiting NCT05502367 - A Study of ABI-2280 Vaginal Tablet in Participants With Cervical Intraepithelial Neoplasia Phase 1/Phase 2
Completed NCT02494310 - HRME: Screening for Cervical Cancer and Its Precursors in Low‐Resource Settings N/A
Active, not recruiting NCT03429582 - Comparison of Cervical CIN II/III Treatment Outcomes With Thermal Ablation Device N/A
Active, not recruiting NCT02140021 - Biospecimen Collection and Testing for the Prevalence of Anal Dysplasia and Anal Cancer in Patients With Cervical, Vaginal and Vulvar Dysplasia and Cancer N/A
Not yet recruiting NCT05510830 - Diagnostic Cervical Conization for Persistent Infection or Integration of HPV N/A
Completed NCT02237326 - Visual Inspection With Acetic Acid Compared to Lugol's Iodine in HIV-infected Women N/A
Completed NCT00316706 - Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine Phase 3
Withdrawn NCT03143491 - Study of SOR007 Ointment for Cervical Intraepithelial Neoplasia (CIN) Phase 2
Completed NCT03293628 - Comparing Two Techniques of Haemostasis After Cervical Conization Phase 2
Recruiting NCT05266898 - Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV Phase 4
Completed NCT02481414 - A Clinical Trial of PepCan to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions Phase 2
Completed NCT02247999 - Improving Cervical Cancer Screening Among HIV-Infected Women in India
Recruiting NCT04650711 - Immunohistochemical Staining of p16 for the Screening of Cervical Cancer Phase 2
Recruiting NCT04646954 - DNA Methylation Testing for the Screening of Uterine Cervical Lesion Phase 3
Completed NCT01544478 - V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110) Phase 4